EMC China Lab

ISO 18562:2024 Testing Services

Views :
Update time : 2024-08-07

The China JJR Laboratory is an IEC 17025 and GLP authorized and accredited laboratory, offering ISO 18562:2024 testing services. Based in China, we can help you save 30% on testing costs. Below is a detailed introduction to the ISO 18562 related tests.

 

The ISO 18562 series of standards was initially published in 2017, comprising ISO 18562-1, ISO 18562-2, ISO 18562-3, and ISO 18562-4, with ISO 18562-1 serving as the overarching standard, similar to ISO 10993-1. These four standards address specific needs for the biological evaluation of gas pathways in medical devices, which are not fully covered by ISO 10993-1.

 

ISO 18562:2024 Testing Services(图1)


The 2017 version of this series aimed to cover only the most common potentially harmful substances. Some believed it would be better to publish an effective document to test most currently known substances of interest. By using the TTC (Threshold of Toxicological Concern) approach, this document has the potential to evaluate the safety of virtually any compound released from respiratory medical device gas pathways, with only a few exceptions (e.g., PCBs, dioxins), rather than just the most commonly found potentially harmful substances.

 

In March 2024, the ISO 18562 series was updated to include numerous additions and changes. Key updates to ISO 18562-1 are highlighted below.

 

The updated standards have also been recognized by the FDA, which has provided a 2-year transition period. They will become mandatory on July 5, 2026, replacing the 2017 versions.

 

Applicable Devices for ISO 18562 Series Standards

For detailed information on applicable devices, please refer to the scope section of ISO 18562-1.

 

The ISO 18562 series standards apply to all medical devices, accessories, or attachments that contain gas pathways intended to provide respiratory care or substance delivery to patients via the respiratory tract in various environments. These gas pathway devices include:

- Ventilators

- Anaesthesia workstations (including gas mixers)

- Breathing systems

- Oxygen conserving equipment

- Oxygen concentrators

- Nebulizers

- Low-pressure hose assemblies

- Humidifiers

- Heat and moisture exchangers

- Respiratory gas monitors

- Respiration monitors

- Masks

- Medical respiratory personal protective equipment

- Mouthpieces

- Resuscitators

- Breathing tubes

- Breathing system filters

- Y-pieces

- Any respiratory accessories intended to be used with these medical devices

 

Additionally, the enclosed space of pediatric incubators, including air cushions and the inner surface of oxygen hoods, are considered gas pathways.

 

The ISO 18562 series does not address the biological evaluation of device surfaces in direct contact with patients or users. The requirements for direct contact surfaces should follow the ISO 10993 series of standards.

 

The following situations are also not covered by this series of standards:

- Any biological hazards arising from mechanical damage.

- Contamination of the gas supply already present in the device during normal use.

 

Major Updates in ISO 18562-1

- Added informative mapping annexes to relevant regulatory requirements.

- Clarified terms and definitions used in the document.

- Expanded the patient groups to include premature infants, small children, children, and adolescents.

- Introduced inhalation dose.

- Changed the threshold of toxicological concern.

- Expanded the range of volatile organic substances that are tested.

- Clarified the appropriate breathing gas volumes to be used in testing for volatile organic substances.

- Clarified the appropriate breathing gas volumes to be used in the analysis.

 

ISO 18562-1 does not address all potential biological hazards related to gas pathways. Additional evaluations might be appropriate. These evaluations may require further risk control before completing the biological assessment.

 

The series may be expanded with new standards in the future to address other aspects of biological testing, including additional contaminants potentially arising from drugs and anesthetics added to the gas pathways and potential contaminants from the emission of inorganic gases such as ozone, CO, and CO2.


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
Introduction to Taiwan BSMI & NCC Certificatio Introduction to Taiwan BSMI & NCC Certificatio
09 .06.2024
As is well known, electronic products entering Taiwan are subject to regulation in terms of Electrom...
WiFi Router CE Certification Testing WiFi Router CE Certification Testing
09 .05.2024
WiFi router CE certification ensures compliance with European standards through testing for frequenc...
CE certification: Wireless vs. Non-Wireless Produc CE certification: Wireless vs. Non-Wireless Produc
09 .05.2024
Wireless products require the RED directive for CE certification, covering radio transmission. Non-w...
What is CE Certification for Wireless Products? What is CE Certification for Wireless Products?
09 .05.2024
CE certification ensures wireless products comply with EU directives like RED 2014/53/EU, RoHS, and ...
How Much Does a Skin Irritation Test Cost? How Much Does a Skin Irritation Test Cost?
09 .05.2024
The fee for a ISO 10993-23:2021 skin irritation test provided by China‘s JJR is $700, testing time o...
How much does ISO 10993-5 Cytotoxicity Testing cos How much does ISO 10993-5 Cytotoxicity Testing cos
09 .05.2024
How much does ISO 10993-5 cytotoxicity testing cost? costs $500, takes two weeks, and follows the MT...
Cytotoxicity Test ISO 10993-5 Cytotoxicity Test ISO 10993-5
09 .05.2024
China’s JJR Lab performs cytotoxicity tests (ISO 10993-5) on medical devices and biomaterials, evalu...
What are the CE EMC testing standards for sensors? What are the CE EMC testing standards for sensors?
09 .04.2024
CE EMC Testing Standards for Sensors: Includes Conducted & Radiated Emission, Harmonic, Flicker,...

Leave Your Message